"Preliminary analysis shows that these patients are relieved of their symptoms within 24 hours of the monoclonal therapy and their RT-PCR reports also showed viral clearance within a week," Asian Institute of Gastroenterology (AIG) Chairman, Dr D. Nageshwar Reddy, told IANS on Tuesday.

 

This is the first of its kind study in India where experts are looking for the efficacy of this monoclonal antibodies cocktail, especially with the Delta variant (B.1.617), of the virus. "Our plan is to include at least 100 patients for this study. Already 50 patients have been given the drug and we are following up these patients," he said.

 

The patients were given the single dose monoclonal antibodies cocktail drug (casirivimab and imdevimab) within 5 days of their first symptom onset. These patients are in various age groups but majorly 65 plus with comorbidities like diabetes, hypertension, and obesity. Those who were in younger age group were in high-risk category including being on immunosuppressants. According to Dr Reddy, the results till now have been consistent among all these patients.

 

"Studies which were conducted in the US showed that this drug cocktail is effective against the Alpha, Beta and Gamma variants of the virus. The primary objective of the study that we are conducting is to see the efficacy of this monoclonal therapy on the Delta variant (B.1.617) that is now the most prevent strain," he said.

 

The combination of drugs that is being currently used in this antibody cocktail is made by Roche and marketed by Cipla in India. This contains two monoclonal antibodies, Casirivimab and Imdevimab.

 

In India, Zydus recently got the approval to conduct clinical trials by the Subject Expert Committee of the Central Drugs Standard Control Organisation for their antibody cocktail. Currently, the cost of the Roche antibody cocktail comes around Rs 60,000.

 

Patients over 65, obese patients, with uncontrolled diabetes, cardiovascular patients, chronic kidney disease patients and those who are under immunosuppressants like cancer patients are ideal candidates for this treatment.

 

"The timing also must be appropriate where it needs to be given within three to seven days at max. This can be given to patients above 55 if they have heart related issues like hypertension," Dr Reddy said.

 

"Pregnant women and children below 12 years of age are not supposed to be given this treatment as we don't have enough safety data for this subset of patients," he added.

 

Dr Reddy had earlier cautioned against irrational use of antibody cocktails. "This treatment has the potential to increase mutant variants and that is why irrational use of these antibodies' cocktails should be absolutely discouraged," he said.

 

Clinical studies published in peer-reviewed journals including the New England Journal of Medicine have shown that antibody cocktails reduce hospitalisation or death by over 70 per cent, including a drastic reduction in viral clearance.

 

Roche's antibody cocktail was given to then US President Donald Trump when he contracted Covid-19 last year.

 

The doctors say that the cocktail is to be given only in a hospital setting where there is provision to activate the emergency medical system immediately following any infusion-related adverse reaction.